PRIMARY PURPOSE OF POSITION:
The Drug Safety Physician (DSP) is accountable for all safety related aspects of a product in LCT stage or a group of products in the early exploratory phase or mature stage, including but not limited to single case assessment, aggregate reporting, integrated signal prediction/detection (ISP/ISD), integrated risk management process (ISMP) & comparative benefit risk (in collaboration with Clinical Science and Regulatory) throughout the life cycle.
The DSP is consistently willing and able to be successful when employed on the most demanding and complex tasks; has a high degree of independence and autonomy, requiring minimal supervision; has a breadth of knowledge and experience across therapeutic areas and/or stages of drug development; is widely respected by other members of the organization for their contribution and competence; acts as a coach, guide, and mentor; and makes a contribution to the department beyond the bounds of routine responsibilities (e.g. in cross-functional teams and working groups).
MAJOR DUTIES OF POSITION:
• In contributing to the development of the TPP, the key claims and other life cycle strategic planning documents, the DSP is responsible for the safety components and co-responsible for the benefit/risk components together with the Clinical representative
• Contributes to the clinical development plan (CDP) throughout the exploratory and confirmatory phase together with the Clinical representative in order to optimize the benefit/risk profile
• The DSP is responsible for the safety components of the clinical study protocols. For studies that are performed under the responsibility of Medical Affairs in Head Office or in the Affiliates, the DSP is responsible for ensuring the inclusion of minimal safety standards that should be implemented; Medical Affairs is responsible for the implementation.
• The DSP is accountable for the safety components of the study reports, aggregate reports and high level regulatory documents
• Supports the clinical and life cycle teams in bringing the safety expertise in interaction with Health Authorities, Data Safety Monitoring Boards and Investigators
• Acquires and contributes knowledge of relevant drug class and/or competitor safety issues. Provides safety strategy , identifies potential clinical safety issues and recommends appropriate safety monitoring measures.
• Initiate (in phase 0) and maintains the Master Plan support throughout the life cycle and ensures Periodic Safety Update Reports (PSURs) are of high quality and produced in a timely manner
• Contributes to the timely & quality submissions of the presentations to other members of the team
• Contributes to the timely & quality submissions of the presentations relevant assigned data review committees
• Is responsible for the submissions and the presentations to the Global Product Safety Evaluation Committee (GPSEC), ensures that important safety issues are brought up to the GPSEC in a timely fashion and ensures high quality presentations
• Contributes to IND/CTAs, DSURs, clinical study reports, annual safety reports, project plans, project documents and presentations
• Contributes to the scientific publications (abstracts, posters, papers) for scientific meetings/journals and approves the submissions from a safety perspective
• Strategic contribution to the development of key safety messages for internal communications and reviews all communication to the public from a safety point of view
• Keeps PVU Heads including EU QPPV, PV team members fully informed of any changes to benefit/risk, and where appropriate performs tasks as delegated by the PVU Heads including EU QPPV.
• The DSP enables / facilitates the transition of appropriate drug candidates from exploratory to confirmatory development for all aspects pertinent to safety. Likewise they are responsible for the transition of products from LCT stage to mature stage when there are no longer any global clinical development activities nor any significant further development.
KNOWLEDGE AND SKILL REQUIREMENTS:
• Minimum 10 or more years relevant pharmaceutical/biotechnology industry experience in pharmacovigilance
• Required: Physician who would be eligible for medical practice in EU or in US (or equivalent such as Switzerland, Australia, Canada, New Zealand,); ophthalmologist strongly preferred; or
industry ophthalmology experience will also be considered
• At least 2 year’s experience in clinical practice
• Significant experience of drug discovery or development including the evaluation and interpretation of scientific and clinical data.
• Demonstrated knowledge of Safety Science across a breadth of therapeutic areas particularly in relation to issue management and signal detection and evaluation.
• Solid knowledge and understanding of US and EU pharmacovigilance regulatory requirements and general regulatory expectations
• Proven experience in proactively managing a team of individuals located across a number of sites and in leading them to optimize their performance and contribution. Proven ability to coach and develop people.
• Demonstrated experience of proactively driving a variety of tasks and projects and delegating to a team. Able to manage budget and timelines.
• Fluent in spoken and written English
• Strong written and verbal communication skills to a variety of levels and teams, internally and externally. Demonstrated persuasion, influencing and negotiation skills.
• Ability to operate objectively and independently as a leader and as a member of a team, as required
• Ability to interact effectively in a multifunctional and multicultural team setting (Safety team, Global Development Team, Life Cycle Team)
• Ability to interact with Health Authorities as the primary contact person for safety aspects in face to face meetings
• Computer literacy and familiarity with relevant software and systems
WORK ENVIRONMENT and ENVIRONMENTAL CONDITIONS:
The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.